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From California Milk to Nara Cans: The Supply Chain Behind the Second Infant Formula Botulism Outbreak

by | Nov 2, 2026 | Law | 0 comments

In 2026 Nara Organics sold its formula as a “European-made” product, manufactured in Germany. But the milk inside those cans started on California dairy farms. It was the same organic milk, from the same supplier, dried by the same cooperative, that FDA tied to the ByHeart infant botulism outbreak in November 2025.

That is the story of the second infant formula botulism outbreak in seven months. It is a supply chain that crossed an ocean twice and passed through six companies before it reached a baby’s bottle. Below, I walk through each link in that chain, what FDA has found so far, and what is still unanswered.
 
The outbreak
 
Four infants in California, Pennsylvania and Washington were hospitalized with type A infant botulism after drinking Nara Organics Whole Milk Organic Powdered Infant Formula. All four fell ill in April and May 2026, all four were boys under five months old, and all four were treated with BabyBIG.
 
FDA and CDC contacted Nara late on Friday, June 12. Nara recalled every lot the next day, calling it a step taken “out of an abundance of caution.” On July 6, FDA reported that an opened can of Nara formula from one sick baby’s home tested positive for Clostridium botulinum.
 
On August 27, FDA declared the outbreak over and released its key supply chain finding. The Nara lots linked to the illnesses were made with milk from Organic West Milk Inc. and spray dried by Dairy Farmers of America — the same two suppliers behind the ByHeart botulism outbreak. Whole genome sequencing also matched an infant who drank Nara formula to the ByHeart outbreak. FDA concluded that the two outbreaks share a common source of contamination.
 
The ByHeart outbreak
 
Nara was the second infant botulism outbreak. The first, linked to ByHeart Whole Nutrition infant formula, was far larger. When CDC declared it over on February 26, 2026, it counted 48 infants with infant botulism — 28 confirmed and 20 probable — in 17 states. All 48 were hospitalized. No deaths were reported.
 
California’s Infant Botulism Treatment and Prevention Program spotted the problem in early November 2025, after an unusual rise in cases among babies fed ByHeart. ByHeart first recalled two lots, then every ByHeart product days later. Because illnesses traced back as far as December 2023, CDC widened its case definition to cover any infant with botulism exposed to ByHeart since the formula launched in March 2022.
 
Testing found C. botulinum in opened and sealed ByHeart cans, in ByHeart’s base powder, and in organic whole milk powder. FDA identified 17 different strains of the bacteria across patients, product and ingredients. The milk powder came from Organic West Milk and was dried at Dairy Farmers of America’s plant in Fallon, Nevada, where FDA itself collected two matching isolates.
 
The link between Nara and ByHeart
 
FDA has tied the two outbreaks together in three ways.

  1. Same milk. The Nara lots linked to illness were made with organic whole milk from Organic West, ByHeart’s milk supplier.
  2. Same dryer. That milk was spray dried by Dairy Farmers of America, the same processor that dried ByHeart’s milk powder.
  3. Same bacteria. Whole genome sequencing matched a Nara baby’s C. botulinum to bacteria from a ByHeart baby, from ByHeart’s base powder and from sealed ByHeart cans.

From that evidence, FDA concluded that the two outbreaks share a common source of contamination. Put plainly, it appears to be one contamination problem in one supply of organic whole milk powder, sold under two brands. ByHeart’s babies got sick first; Nara’s babies got sick after ByHeart’s recall, because no one had connected Organic West’s milk and Dairy Farmers of America to Nara’s formula.

The common thread is whole milk. Many U.S. infant formulas are built on skim milk with added plant oils. ByHeart and Nara both broke from that model, and both sold parents on whole milk as the reason to pay a premium. That selling point is exactly where the two outbreaks meet: organic whole milk powder was the ingredient they shared, and it is where FDA found C. botulinum. Brands built on that ingredient had every reason to test it for spores.

ByHeart sent its customers to Nara

The connection is not only on paper. When ByHeart recalled all of its formula in November 2025, it pointed its customers to Nara. A November 11, 2025 ByHeart Instagram post recommended Nara products and offered a 20 percent discount code to help families make the switch. ByHeart deleted the post in June 2026, after Healthbeat asked about it, saying it removed the post for safety reasons following the Nara news.

ByHeart says the two companies have no corporate, financial, contractual or manufacturing relationship. But parents who followed ByHeart’s advice moved their babies from one whole milk formula to another that, FDA later found, was made with milk from the same suppliers. The ByHeart recall took one brand off the shelves. It did not take that milk out of the formula supply.

From California dairy to Nara can

Piecing together FDA’s findings, U.S. Customs records and reporting by Food Safety News, eFoodAlert and the Associated Press, the milk traveled this route:

Nara Organics formula supply chain · farm to infant

The milk crossed the Atlantic as powder, became formula in Germany, was canned in Denmark, and came back to the United States under the Nara label. One link — how the powder got from DFA to Elb-Milch, and who sold it — has not been made public.

The branch to ByHeart matters. In January 2026, the AP reported that the organic whole milk powder that tested positive in the ByHeart outbreak came from Organic West milk dried at DFA’s plant in Fallon, Nevada. FDA’s Nara findings name the same two companies. C. botulinum spores survive pasteurization, so contamination that enters at the milk or drying stage can ride all the way into the finished can.

The incomplete customer list

The most troubling fact in FDA’s report is this. During the ByHeart investigation in late 2025, FDA ran a traceforward to learn whether Organic West sold milk to any other powdered infant formula maker. According to FDA, Organic West gave the agency an incomplete customer list — one that did not show its milk was going to the manufacturer of Nara’s formula.

In January 2026, an owner of Organic West told the Associated Press that the company had not sold organic whole milk powder to any infant formula maker other than ByHeart.

Meanwhile, Nara kept importing formula made with that milk. U.S. Customs records show shipments from Elb-Milch through April 30, 2026. The four Nara babies got sick in April and May. Had FDA known in late 2025 that Organic West’s milk was also going into Nara cans, those babies might never have been exposed.

Nara should have asked

Organic West’s list was not the only safeguard that failed. Nara had its own reasons to ask hard questions, and months to ask them.

ByHeart was Nara’s closest competitor: a premium organic whole milk formula sold to the same parents. When ByHeart recalled every can in November 2025, and FDA traced the problem to contaminated organic whole milk powder, every whole milk formula brand in the country should have asked one question: where does our milk powder come from?

Nara knew spore-forming bacteria were a risk. It told customers it had screened for clostridia from its very first batch. A company that understood that hazard, and watched its nearest competitor’s outbreak trace back to milk powder, should have checked whether its own formula used the same milk or the same dryer.

If Nara asked, it either learned it shared ByHeart’s supply chain and kept selling, or it got an answer it did not verify. If it never asked, that is its own failure. Either way, Nara kept importing formula made with that milk until April 2026 — five months after the ByHeart recall — and four more babies got sick.

What we still don’t know

  • Where the spores got in. FDA says there is not yet enough evidence to tell whether the milk was contaminated before drying or during it.
  • Which DFA plant dried Nara’s milk. ByHeart’s powder was dried at DFA’s Fallon, Nevada plant. FDA’s Nara findings name DFA but not the plant.
  • Who sold the powder to Germany. Organic West resold the dried powder to ByHeart. Whether it, DFA or a broker sold the powder to Elb-Milch has not been made public.
  • Who chose U.S. milk. Nara marketed EU standards. Whether Nara or Elb-Milch decided to use U.S. organic whole milk powder is unknown.
  • What anyone tested. Did Elb-Milch or Nara test incoming powder for C. botulinum spores after the ByHeart recall became public?

Why it matters

Parents who paid a premium for Nara bought a promise of European safety standards. What they got was formula built on the same California milk powder that had already sickened babies through ByHeart. A “Made in Germany” label told them where the formula was mixed, not where its main ingredient came from.

This outbreak also shows how little the system knows about who supplies whom. FDA asked the right question in 2025 and, by its own account, got an incomplete answer. Infant formula supply chains should not depend on a supplier’s voluntary customer list. Ingredient sourcing should be traceable, and whole milk powder destined for infant formula should be tested for C. botulinum spores.

That is why I am filing a citizen petition with FDA, joined by 46 parents of 24 infants sickened in the ByHeart and Nara outbreaks. It asks FDA to add C. botulinum and the other botulinum toxin-producing clostridia to the required tests for powdered infant formula, to require that every lot of whole milk powder and other dairy ingredients test negative before it is used, and to require formula makers to keep records tracing each ingredient lot back to its dryer and its dairy farms. Had those records been required, the shared supply chain would have been sitting in Nara’s files when ByHeart sent its families there.

References

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